MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INTIMA-II Y 24GAX0.75IN PRN/EC SLM; INTERVASCULAR CATHETER

Catalog Number 383033

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the intima-ii y 24gax0.75in prn/ec slm experienced damaged/defective tubing which was noted during use.The following information was provided by the initial reporter: the y-type intima-ii extension tubing was suddenly completely broken when the patient's arm was indwelling on the fourth night without transfusion.The patient was old and the blood was left on the bed through the extension tubing, which greatly frightened the patient and his family members and affected the patient's condition.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 9050923.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a review of the manufacturing process could not identify any contributing factors that could have lead to he observed damage.Based on the event description citing four days of use where the device was operating normally our quality engineers have determined that the root cause for this event is unrelated to the manufacturing process.

Event Description

It was reported that the intima-ii y 24gax0.75in prn/ec slm experienced damaged/defective tubing which was noted during use.The following information was provided by the initial reporter: the y-type intima-ii extension tubing was suddenly completely broken when the patient's arm was indwelling on the fourth night without transfusion.The patient was old and the blood was left on the bed through the extension tubing, which greatly frightened the patient and his family members and affected the patient's condition.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9266718
• MDR Text Key: 180196519
• Report Number: 3006948883-2019-00910
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/03/2022
• Device Catalogue Number: 383033
• Device Lot Number: 9050923
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other